FDA Medical Device Recalls (openFDA)
Carl Zeiss Meditec, Inc.: INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.
- Recall number
- Z-2989-2011
- Recalling firm
- Carl Zeiss Meditec, Inc.
- Product
- INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.
- Status
- Terminated
- Initiated
- 2011-07-01
- Posted
- 2011-08-10
- Terminated
- 2011-10-13
- Reason
- Carl Zeiss Meditec received a report that the INTRABEAM 20 x 20 cm sterile shield's packaging looked wet inside. Investigation found the substance to be Triethylene Glycol,
- Root cause
- Process control
- Action
- Carl Zeiss Meditec, Inc. sent an "Important Field Correction Action" letter dated July 13, 2011 to all affected customers. The letter included description of affected product and problem. Customers are asked to notify the firm if they have experienced any problems with the product and to return any remaining product for replacement upon completion of required testing. Customers are asked to fill out and return an Acknowledgement Form. For additional information contact Carl Zeiss Meditec at (925) 570-4844.
- Quantity
- 8 boxes of 10 sterile packages.
- Distribution
- Nationwide (USA) Distribution including the states of FL, CA, NY, VA and AL.
- Lot, serial or model codes
- Lot 110851; Catalog number 304534-6000-585.
- 510(k) numbers
- ["K051055","K090584"]
- PMA numbers
- not on file
- Product code
- JAD
- Firm FEI
- 2918630
- Firm city
- Dublin
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28